TissueStat TIS-003

GUDID B532TIS0030

The TissueStat Convenience Kit (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a needle gently and precisely through thick, soft tissue facilitating quick placement of sutures and knot tying for tissue approximation and/or ligation.

DURASTAT LLC

Suturing needle holder, single-use

• Primary Device ID: B532TIS0030
• NIH Device Record Key: 0e0d9c8b-9c0a-4986-9d29-fa1a0fc2403a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TissueStat
• Version Model Number: TIS-003
• Catalog Number: TIS-003
• Company DUNS: 080315253
• Company Name: DURASTAT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com
• Phone: 8008048018
• Email: CX@durastat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B532TIS0030 [Primary]

FDA Product Code

• HXK: Holder, Needle; Orthopedic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

On-Brand Devices [TissueStat]

• B532TIS0030: The TissueStat Convenience Kit (TIS-003) is a class I suture deployment device that allows healt
• B532TIS0040: TissueStat 0 PGLA Kit
• B532TIS0010: TissueStat 2-0 PTFE Kit